Observational Study of Baska Mask, a New Supraglottic Airway Device

University College Hospital Galway

Status and phase: Completed; Phase 2

Conditions: Performance and Safety of a New Supraglottic Airway Device

Treatments: Device: Placement and use of Baska mask

Study type: Interventional

Funder types: Other

Identifiers

NCT01496859

C.A.621

Details and patient eligibility

About

The Baska mask is a new supraglottic airway device . The investigators would like to assess its performance in setting in which the current standard - LMA device - is being used.

Full description

Our group has performed a number of studies on novel airway devices. In this study we would like to evaluate a new supraglottic airway named Baska mask. We would like to monitor certain parameters (time to and ease of insertion, failure rate, seal pressures, complications etc) as regarding the performance and safety profile of this device. This is a descriptive case series of patients undergoing airway management under general anaesthesia.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed Consent
• No relevant drug allergies
• Body-mass index (BMI) 20-35
• Age 18-65
• Non-urgent surgery of planned duration 0-2 hrs

Exclusion criteria

• Inability of patient/parent to understand or consent for the trial
• Non-English speakers
• Neck pathology
• Previous or anticipated problems with the upper airway or upper GI tract (reflux, hiatus hernia, oropharyngeal tumour, upper respiratory tract infection in the last 10 days etc)
• BMI >35
• Expected Difficult airway
• Live Pregnancy
• Increased risk for Gastric Aspiration

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Baska

Experimental group

Treatment:

Device: Placement and use of Baska mask